NCT01120184 · ADVERSE EVENTS

Adverse events

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) · Source last updated 2024-03-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).
Other-event reporting threshold: 5%

Safety Population: All randomized participants who received at least one dose of study treatment and the participants were analyzed based on the treatment they actually received (N=353 in Trastuzumab + Taxane arm, N=361 in Trastuzumab Emtansine, Pertuzumab-placebo arm, N=366 in Trastuzumab emtansine + pertuzumab arm).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Trastuzumab + Taxane Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.	81 / 353	342 / 353	Not reported / Not reported
Trastuzumab Emtansine + Placebo Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.	86 / 361	352 / 361	Not reported / Not reported
Trastuzumab Emtansine + Pertuzumab Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.	93 / 366	352 / 366	Not reported / Not reported

Group identifiers: EG000: Trastuzumab + Taxane · EG001: Trastuzumab Emtansine + Placebo · EG002: Trastuzumab Emtansine + Pertuzumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
13
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
5
num At Risk
361
group Id
EG002
num Affected
6
num At Risk
366
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
2
num At Risk
361
group Id
EG002
num Affected
2
num At Risk
366
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Hypercoagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Supraventricular tachycardia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
131
num At Risk
353
group Id
EG001
num Affected
174
num At Risk
361
group Id
EG002
num Affected
192
num At Risk
366
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
173
num At Risk
353
group Id
EG001
num Affected
92
num At Risk
361
group Id
EG002
num Affected
178
num At Risk
366
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
128
num At Risk
353
group Id
EG001
num Affected
120
num At Risk
361
group Id
EG002
num Affected
130
num At Risk
366
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
80
num At Risk
353
group Id
EG001
num Affected
116
num At Risk
361
group Id
EG002
num Affected
120
num At Risk
366
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
53
num At Risk
353
group Id
EG001
num Affected
113
num At Risk
361
group Id
EG002
num Affected
127
num At Risk
366
term
Epistaxis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
59
num At Risk
353
group Id
EG001
num Affected
96
num At Risk
361
group Id
EG002
num Affected
118
num At Risk
366
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
212
num At Risk
353
group Id
EG001
num Affected
26
num At Risk
361
group Id
EG002
num Affected
33
num At Risk
366
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
69
num At Risk
353
group Id
EG001
num Affected
80
num At Risk
361
group Id
EG002
num Affected
111
num At Risk
366
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
76
num At Risk
353
group Id
EG001
num Affected
84
num At Risk
361
group Id
EG002
num Affected
84
num At Risk
366
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
91
num At Risk
353
group Id
EG001
num Affected
83
num At Risk
361
group Id
EG002
num Affected
71
num At Risk
366
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
86
num At Risk
353
group Id
EG001
num Affected
62
num At Risk
361
group Id
EG002
num Affected
89
num At Risk
366
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
72
num At Risk
353
group Id
EG001
num Affected
82
num At Risk
361
group Id
EG002
num Affected
71
num At Risk
366
term
Constipation

Complete source fields

description

event Groups

description
Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
id
EG000
other Num Affected
342
other Num At Risk
353
serious Num Affected
81
serious Num At Risk
353
title
Trastuzumab + Taxane
description
Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
id
EG001
other Num Affected
352
other Num At Risk
361
serious Num Affected
86
serious Num At Risk
361
title
Trastuzumab Emtansine + Placebo
description
Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
id
EG002
other Num Affected
352
other Num At Risk
366
serious Num Affected
93
serious Num At Risk
366
title
Trastuzumab Emtansine + Pertuzumab

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
131
num At Risk
353
group Id
EG001
num Affected
174
num At Risk
361
group Id
EG002
num Affected
192
num At Risk
366
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
173
num At Risk
353
group Id
EG001
num Affected
92
num At Risk
361
group Id
EG002
num Affected
178
num At Risk
366
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
128
num At Risk
353
group Id
EG001
num Affected
120
num At Risk
361
group Id
EG002
num Affected
130
num At Risk
366
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
80
num At Risk
353
group Id
EG001
num Affected
116
num At Risk
361
group Id
EG002
num Affected
120
num At Risk
366
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
53
num At Risk
353
group Id
EG001
num Affected
113
num At Risk
361
group Id
EG002
num Affected
127
num At Risk
366
term
Epistaxis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
59
num At Risk
353
group Id
EG001
num Affected
96
num At Risk
361
group Id
EG002
num Affected
118
num At Risk
366
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
212
num At Risk
353
group Id
EG001
num Affected
26
num At Risk
361
group Id
EG002
num Affected
33
num At Risk
366
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
69
num At Risk
353
group Id
EG001
num Affected
80
num At Risk
361
group Id
EG002
num Affected
111
num At Risk
366
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
76
num At Risk
353
group Id
EG001
num Affected
84
num At Risk
361
group Id
EG002
num Affected
84
num At Risk
366
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
91
num At Risk
353
group Id
EG001
num Affected
83
num At Risk
361
group Id
EG002
num Affected
71
num At Risk
366
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
86
num At Risk
353
group Id
EG001
num Affected
62
num At Risk
361
group Id
EG002
num Affected
89
num At Risk
366
term
Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
72
num At Risk
353
group Id
EG001
num Affected
82
num At Risk
361
group Id
EG002
num Affected
71
num At Risk
366
term
Constipation

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
13
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
5
num At Risk
361
group Id
EG002
num Affected
6
num At Risk
366
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
5
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
2
num At Risk
361
group Id
EG002
num Affected
2
num At Risk
366
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Hypercoagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Cardiac failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
1
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
0
num At Risk
366
term
Pericardial effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (17.1)
stats
group Id
EG000
num Affected
0
num At Risk
353
group Id
EG001
num Affected
0
num At Risk
361
group Id
EG002
num Affected
1
num At Risk
366
term
Supraventricular tachycardia

time Frame

Up to 70 months from randomization until clinical cutoff of 16 September 2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination).

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