NCT03108131 · ADVERSE EVENTS

Adverse events

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors · Source last updated 2025-05-28

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: 3 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Small Bowel Adenocarcinoma Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.	0 / 20	9 / 20	9 / 20

Group identifiers: EG000: Small Bowel Adenocarcinoma

Serious adverse events

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

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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
8
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Gatroesophageal Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Gastrointestinal Disease-Others (Sore Gums)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hemorrhoids

Complete source fields

event Groups

deaths Num Affected
9
deaths Num At Risk
20
description
Must be refractory or intolerant to at least one line of 5FU-based chemotherapy for metastatic disease and must not have clinically symptomatic malignant small bowel obstruction. Cobimetinib (60 mgorally once daily for days 1 - 21) and atezolizumab (840 mg intravenously every 2 weeks) every 28-day cycle.
id
EG000
other Num Affected
9
other Num At Risk
20
serious Num Affected
0
serious Num At Risk
20
title
Small Bowel Adenocarcinoma

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
8
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Tinnitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Retinopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
6
num At Risk
20
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Dry Mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Gatroesophageal Disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Gastrointestinal Disease-Others (Sore Gums)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hemorrhoids

time Frame

3 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice