On Location 2018 ASH Annual Meeting
Compared with event rates at
baseline, at three-year follow-up,
incidence of all clinical adverse
events (AEs) decreased from 308.4
to 170.7 events per 100 patient-
years. The rate of sickle cell–
related events also was reduced
(from 114.5 to 53.0 events per
100 patient-years; p values not
provided), including:
• vaso-occlusive pain: 98.3 to
44.6 events per 100 patient-
years baseline, during the treatment
phase (though p values were not
provided):
• acute chest syndrome or
pneumonia: 9.0 to 5.0 events
per 100 patient-years • Rates of malaria infection
dropped from 47.8 to 22.3
events per 100 patient-years
The data also alleviated concerns
about infections in hydroxyurea-
treated patients. Compared with
• Rates of nonmalaria infection
dropped from 142.5 to 90.0
events per 100 patient-years
• Rates of severe, grade ≥3
infections dropped from 28.9
to 8.0 events per 100 patient-
years
“Effects on all-cause mortality
were also pronounced,” the au-
thors added, “with 3.6 deaths per
100 patient-years during screen-
ing decreasing to 1.1 deaths per
100 patient-years on hydroxyurea
REVLIMID [lenalidomide] capsules, for oral use
b
All grade 3 or 4 treatment-emergent AEs in at least 1% of patients in the
Lenalidomide Maintenance group and at least 1% higher frequency (%) than
the Placebo Maintenance group.
c All serious treatment-emergent AEs in at least 1% of patients in the
Lenalidomide Maintenance group and at least 1% higher frequency (%) than
the Placebo Maintenance group.
d Footnote “a” not applicable for either study
e Footnote “b” not applicable for either study
@ -ADRs where at least one resulted in a fatal outcome
% - ADRs where at least one was considered to be Life Threatening (if the
outcome of the event was death, it is included with death cases)
# - All adverse reactions under Body System of Infections and Infestation
except for rare infections of Public Health interest will be considered listed
*Adverse Reactions for combined ADR terms (based on relevant TEAE PTs
included in Maintenance Studies 1 and 2 [per MedDRA v 15.1]):
Pneumonias Bronchopneumonia,. Lobar pneumonia, Pneumocystis jiroveci
pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella,
Pneumonia mycoplasmal, Pneumonia pneumococcal, Pneumonia
streptococcal, Pneumonia viral, Lung disorder, Pneumonitis
Sepsis: Bacterial sepsis, Pneumococcal sepsis, Sepsis, Septic shock,
Staphylococcal sepsis
Peripheral neuropathy: Neuropathy peripheral, Peripheral motor neuropathy,
Peripheral sensory neuropathy, Polyneuropathy
Deep vein thrombosis: Deep vein thrombosis, Thrombosis, Venous
thrombosis
After At Least One Prior Therapy for MM:
Data were evaluated from 703 patients in two studies who received at
least one dose of REVLIMID/dexamethasone (353 patients) or placebo/
dexamethasone (350 patients).
In the REVLIMID/dexamethasone treatment group, 269 patients (76%)
had at least one dose interruption with or without a dose reduction of
REVLIMID compared to 199 patients (57%) in the placebo/dexamethasone
treatment group. Of these patients who had one dose interruption with or
without a dose reduction, 50% in the REVLIMID/dexamethasone treatment
group had at least one additional dose interruption with or without a dose
reduction compared to 21% in the placebo/dexamethasone treatment
group. Most adverse reactions and Grade 3/4 adverse reactions were
more frequent in patients who received the combination of REVLIMID/
dexamethasone compared to placebo/dexamethasone.
Tables 6, 7, and 8 summarize the adverse reactions reported for
REVLIMID/dexamethasone and placebo/dexamethasone groups.
Table 6: Adverse Reactions Reported in ≥5% of Patients and
with a ≥2% Difference in Proportion of Patients Between the
REVLIMID/dexamethasone and Placebo/dexamethasone Groups
Body System
REVLIMID/Dex* Placebo/Dex *
Adverse Reaction
(N=353)
(N=350)
n (%)
n (%)
Blood and lymphatic system disorders
Neutropenia %
149 (42.2)
22 ( 6.3)
Anemia @
111 (31.4)
83 (23.7)
Thrombocytopenia @
76 (21.5)
37 (10.6)
Leukopenia
28 ( 7.9)
4 ( 1.1)
Lymphopenia
19 ( 5.4)
5 ( 1.4)
General disorders and administration site conditions
Fatigue
155 (43.9)
146 (41.7)
Pyrexia
97 (27.5)
82 (23.4)
Peripheral edema
93 (26.3)
74 (21.1)
Chest Pain
29 ( 8.2)
20 ( 5.7)
Lethargy
24 ( 6.8)
8 ( 2.3)
Gastrointestinal disorders
Constipation
143 (40.5)
74 (21.1)
Diarrhea @
136 (38.5)
96 (27.4)
Nausea @
92 (26.1)
75 (21.4)
Vomiting @
43 (12.2)
33 ( 9.4)
Abdominal Pain @
35 ( 9.9)
22 ( 6.3)
Dry Mouth
25 ( 7.1)
13 ( 3.7)
(continued)
Cosmos Communications
Table 6: Adverse Reactions Reported in ≥5% of Patients and
with a ≥2% 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 (%)
Musculoskeletal and connective tissue disorders
Muscle cramp
118 (33.4) 74 (21.1)
91 (25.8) 65 (18.6)
Back pain
Bone Pain 48 (13.6) 39 (11.1)
Pain in Limb 42 (11.9) 32 ( 9.1)
Dizziness 82 (23.2) 59 (16.9)
Tremor 75 (21.2) 26 ( 7.4)
Nervous system disorders
Dysgeusia 54 (15.3) 34 ( 9.7)
Hypoesthesia 36 (10.2) 25 ( 7.1)
Neuropathyª 23 ( 6.5) 13 ( 3.7)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 83 (23.5) 60 (17.1)
Nasopharyngitis 62 (17.6) 31 ( 8.9)
Pharyngitis 48 (13.6) 33 ( 9.4)
Bronchitis 40 (11.3) 30 ( 8.6)
Upper respiratory tract infection 87 ( 24.6) 55 (15.7)
Pneumonia @ 48 ( 13.6) 29 ( 8.3)
Urinary Tract Infection 30 ( 8.5) 19 ( 5.4)
Sinusitis 26 ( 7.4) 16 ( 4.6)
Rash c 75 ( 21.2) 33 ( 9.4)
Sweating Increased 35 ( 9.9) 25 ( 7.1)
Dry Skin 33 ( 9.3) 14 ( 4.0)
Pruritus 27 ( 7.6) 18 ( 5.1)
Infections b
and infestations
Skin and subcutaneous system disorders
Metabolism and nutrition disorders
Anorexia 55 ( 15.6) 34 ( 9.7)
Hypokalemia 48 ( 13.6) 21 ( 6.0)
Hypocalcemia 31 ( 8.8) 10 ( 2.9)
Appetite Decreased 24 ( 6.8) 14 ( 4.0)
Dehydration 23 ( 6.5) 15 ( 4.3)
Hypomagnesemia 24 ( 6.8) 10 ( 2.9)
69 ( 19.5) 52 (14.9)
61 ( 17.3) 40 (11.4)
Deep vein thrombosis % 33 ( 9.3) 15 ( 4.3)
Hypertension 28 ( 7.9) 20 ( 5.7)
Hypotension 25 ( 7.1) 15 ( 4.3)
Investigations
Weight Decreased
Eye disorders
Blurred vision
Vascular disorders
1
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Q2