es of an adverse reaction is counted only once under the applicable Body System/Adverse Reaction.
a All treatment-emergent adverse reactions in at least 5.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 2.0% higher frequency (%) in either the Rd Continuous or Rd18 Arms compared to the MPT Arm.
b All grade 3 or 4 treatment-emergent adverse reactions in at least 1.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 1.0% higher frequency (%) in either the Rd Continuous or Rd18 Arms compared to the MPT Arm.
c Serious treatment-emergent adverse reactions in at least 1.0% of subjects in the Rd Continuous or Rd18 Arms and at least a 1.0% higher frequency (%) in either the Rd Continuous or Rd18 Arms compared to the MPT Arm.
d Preferred terms for the blood and lymphatic system disorders body system were included by medical judgment as known adverse reactions for Rd Continuous/Rd18, and have also been reported as serious.
e Footnote “a” not applicable
f Footnote “b” not applicable.
@ - 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)
*Adverse reactions include in combined adverse reaction terms:
Abdominal Pain: Abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain
Pneumonias: Pneumonia, lobar pneumonia, pneumonia pneumococcal, bronchopneumonia, pneumocystis jiroveci pneumonia, pneumonia legionella, pneumonia staphylococcal, pneumonia klebsiella, atypical pneumonia, pneumonia bacterial, pneumonia escherichia, pneumonia streptococcal, pneumonia viral
Sepsis: Sepsis, septic shock, urosepsis, escherichia sepsis, neutropenic sepsis, pneumococcal sepsis, staphylococcal sepsis, bacterial sepsis, meningococcal sepsis, enterococcal sepsis, klebsiella sepsis, pseudomonal sepsis
Rash: Rash, rash pruritic, rash erythematous, rash maculo-papular, rash generalised, rash papular, exfoliative rash, rash follicular, rash macular, drug rash with eosinophilia and systemic symptoms, erythema multiforme, rash pustular
Deep Vein Thrombosis: Deep vein thrombosis, venous thrombosis limb, venous thrombosis
Body System
Adverse Reaction All Adverse Reactionsa Grade 3/4 Adverse Reactionsb
Rd
Continuous
(N = 532) Rd18
(N = 540) MPT
(N = 541) Rd
Continuous
(N = 532) Rd18
(N = 540) MPT
(N = 541)
General disorders and administration site conditions
Fatigue% 173 (32.5) 177 (32.8) 154 (28.5) 39 (7.3) 46 (8.5) 31 (5.7)
Asthenia 150 (28.2) 123 (22.8) 124 (22.9) 41 (7.7) 33 (6.1) 32 (5.9)
Pyrexiac 114 (21.4) 102 (18.9) 76 (14.0) 13 (2.4) 7 (1.3) 7 (1.3)
Non-cardiac chest pain f 29 (5.5) 31 (5.7) 18 (3.3) <1% <1% <1%
Gastrointestinal disorders
Diarrhea 242 (45.5) 208 (38.5) 89 (16.5) 21 (3.9) 18 (3.3) 8 (1.5)
Abdominal pain% f 109 (20.5) 78 (14.4) 60 (11.1) 7 (1.3) 9 (1.7) <1%
Dyspepsia f 57 (10.7) 28 (5.2) 36 (6.7) <1% <1% 0 (0.0)
Musculoskeletal and connective tissue disorders
Back painc 170 (32.0) 145 (26.9) 116 (21.4) 37 (7.0) 34 (6.3) 28 (5.2)
Muscle spasms f 109 (20.5) 102 (18.9) 61 (11.3) <1% <1% <1%
Arthralgia f 101 (19.0) 71 (13.1) 66 (12.2) 9 (1.7) 8 (1.5) 8 (1.5)
Bone pain f 87 (16.4) 77 (14.3) 62 (11.5) 16 (3.0) 15 (2 |
