CLINICAL NEWS
[p value not provided].”
“Because of its positive impact
on anemia, clinical events, and
quality of life, hydroxyurea can
now be considered for routine care
of children with SCA in Africa,”
Dr. Tshilolo concluded.
The study’s implications are
limited by the single-arm design,
and Dr. Tshilolo noted that the
costs of hydroxyurea treatment and
associated laboratory monitoring
will be a major factor limiting more
widespread use of the drug to treat
SCA in Africa.
“The current cost of treatment
is beyond the daily wage of most
families living in sub-Saharan
Africa,” he said. However, REACH
participants received the hydroxy-
urea capsules, all lab tests, and
transportation to clinic visits at no
charge, which may have contrib-
uted to the high rates of retention
and adherence to treatment on the
study. “We hope that treatment
will be made available to more
patients through outside financial
support, as is the case with treat-
ment for HIV infection in several
African countries.”
The authors report financial
relationships with Addmedica, the
manufacturers of hydroxyurea,
and Bristol-Myers Squibb, which
provided funding for the trial.
REFERENCE
Tshilolo L, Tomlinson G, Williams TN, et al. Realizing
effectiveness across continents with hydroxyurea (REACH):
a prospective multi-national trial of hydroxyurea for sickle
cell anemia in sub-Saharan Africa. Abstract #3. Presented
at the 2018 ASH Annual Meeting, December 2, 2018; San
Diego, CA.
REVLIMID [lenalidomide] capsules, for oral use
Table 7: Grade 3/4 Adverse Reactions Reported in ≥2% Patients and
With a ≥1% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone groups
Body System
Adverse Reaction
REVLIMID/Dex &
(N=353)
n (%)
Placebo/Dex &
(N=350)
n (%)
12 ( 3.4) Febrile Neutropenia %
43 ( 12.2) 22 ( 6.3) Vascular disorders
35 ( 9.9) 20 ( 5.7)
118 ( 33.4)
Thrombocytopenia @ Anemia @ Leukopenia 14 ( 4.0) 1 ( 0.3)
Lymphopenia 10 ( 2.8) 4 ( 1.1)
8 ( 2.3) 0 ( 0.0)
Febrile Neutropenia %
General disorders and administration site conditions
Fatigue
23 ( 6.5)
17 ( 4.9)
Vascular disorders
Deep vein thrombosis %
REVLIMID/Dex &
(N=353)
n (%)
Body System
Adverse Reaction
Deep vein thrombosis %
Pneumonia @
12 ( 3.4)
Pulmonary embolism @
Atrial fibrillation @
Gastrointestinal disorders
19 ( 5.4)
1 ( 0.3)
Metabolism and nutrition disorders
Hypokalemia 17 ( 4.8) 5 ( 1.4)
Hypocalcemia 13 ( 3.7) 6 ( 1.7)
9 ( 2.5) 0 ( 0.0)
Hypophosphatemia
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism @
Respiratory
Distress @
14 ( 4.0) 3 ( 0.9)
4 ( 1.1) 0 ( 0.0)
Musculoskeletal and connective tissue disorders
Muscle weakness
20 ( 5.7) 10 ( 2.9)
Gastrointestinal disorders
Diarrhea @
11 ( 3.1) 4 ( 1.1)
Constipation 7 ( 2.0) 1 ( 0.3)
Nausea @ 6 ( 1.7) 2 ( 0.6)
13 ( 3.7) 4 ( 1.1)
Cardiac disorders
Atrial fibrillation @
Tachycardia 6 ( 1.7) 1 ( 0.3)
Cardiac Failure Congestive @ 5 ( 1.4) 1 ( 0.3)
Syncope 10 ( 2.8) 3 ( 0.9)
Dizziness 7 ( 2.0) 3 ( 0.9)
Cataract 6 ( 1.7) 1 ( 0.3)
Cataract Unilateral 5 ( 1.4) 0 ( 0.0)
10 ( 2.8) 6 ( 1.7)
Nervous System disorders
Eye Disorders
Psychiatric Disorder
Depression
Cosmos Communications
11 ( 3.1)
33 ( 9.3) 21 ( 6.0)
13 ( 3.7) 3 ( 0.9)
11 ( 3.1) 2 ( 0.6)
5 ( 1.4) 0 ( 0.0)
7 ( 2.0) 3 ( 0.9)
6 ( 1.7) 2 ( 0.6)
4 ( 1.1) 0 ( 0.0)
Nervous system disorders
Cerebrovascular accident @
5 ( 1.4) 26 ( 7.4)
Cardiac disorders
Pneumonia @ 30 ( 8.5) 0 ( 0.0)
Respiratory, thoracic, and mediastinal disorders
Cardiac Failure Congestive @
29 ( 8.2)
6 ( 1.7)
Infections and infestations
Infections and infestations
Urinary Tract Infection
Placebo/Dex &
(N=350)
n (%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders
Neutropenia %
Table 8: Serious Adverse Reactions Reported in ≥1% Patients and
With a ≥1% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone Groups
Diarrhea @
Musculoskeletal and connective
tissue disorders
Bone Pain
For Tables 6, 7 and 8 above:
@ - adverse reactions in which at least one resulted in a fatal outcome
% - adverse reactions in which at least one was considered to be life
threatening (if the outcome of the reaction was death, it is included with
death cases)
Median duration of exposure among patients treated with REVLIMID/
dexamethasone was 44 weeks while median duration of exposure among
patients treated with placebo/dexamethasone was 23 weeks. This should be
taken into consideration when comparing frequency of adverse reactions
between two treatment groups REVLIMID/dexamethasone vs.
placebo/dexamethasone.
Venous and Arterial Thromboembolism [see Boxed Warning, Warnings
and Precautions (5.4)]
VTE and ATE are increased in patients treated with REVLIMID.
Deep vein thrombosis (DVT) was reported as a serious (7.4%) or
severe (8.2%) adverse drug reaction at a higher rate in the REVLIMID/
dexamethasone group compared to 3.1 % and 3.4% in the placebo/
dexamethasone group, respectively in the 2 studies in patients with at
least 1 prior therapy with discontinuations due to DVT adverse reactions
reported at comparable rates between groups. In the NDMM study, DVT
was reported as an adverse reaction (all grades: 10.3%, 7.2%, 4.1%), as
a serious adverse reaction (3.6%, 2.0%, 1.7%), and as a Grade 3/4
adverse reaction (5.6%, 3.7%, 2.8%) in the Rd Continuous, Rd18, and
MPT Arms, respectively. Discontinuations and dose reductions due to
DVT adverse reactions were reported at comparable rates between the
Rd Continuous and Rd18 Arms (both <1%). Interruption of REVLIMID
treatment due to DVT adverse reactions was reported at comparable
rates between the Rd Continuous (2.3%) and Rd18 (1.5%) arms.
Pulmonary embolism (PE) was reported as a serious adverse drug
reaction (3.7%) or Grade 3/4 (4.0%) at a higher rate in the REVLIMID/
dexamethasone group compared to 0.9% (serious or grade 3/4) in the
placebo/dexamethasone group in the 2 studies in patients with, at least
1 prior therapy, with discontinuations due to PE adverse reactions
reported at comparable rates between groups. In the NDMM study,
the frequency of adverse reactions of PE was similar between the
Rd Continuous, Rd18, and MPT Arms for adverse reactions (all grades:
3.9%, 3.3%, and 4.3%, respectively), serious adverse reactions (3.8%,
2.8%, and 3.7%, respectively), and grade 3/4 adverse reactions (3.8%,
3.0%, and 3.7%, respectively).
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