NCT04209465 · ADVERSE EVENTS

Adverse events

A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. · Source last updated 2025-04-17

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: Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Dose Escalation 25 mg QD Patients who received doses at 25 mg once daily under fasted conditions.	0 / 1	1 / 1	1 / 1
Dose Escalation 50 mg QD Patients who received doses at 50 mg once daily under fasted conditions.	0 / 1	1 / 1	0 / 1
Dose Escalation 100 mg QD Patients who received doses at 100 mg once daily under fasted conditions.	0 / 1	1 / 1	0 / 1
Dose Escalation 200 mg QD Patients who received doses at 200 mg once daily under fasted conditions.	2 / 2	2 / 2	0 / 2
Dose Escalation 400 mg QD Patients who received 400 mg once daily under fasted conditions.	2 / 10	10 / 10	2 / 10
Dose Escalation 800 mg QD Patients who received 800 mg once daily under fasted conditions.	8 / 18	18 / 18	7 / 18
Dose Escalation 800 mg QD NF Patients who received 800 mg once daily under not fasted (NF) conditions.	1 / 13	13 / 13	2 / 13
Dose Escalation 1000 mg QD Patients who received 1000 mg once daily under fasted conditions.	1 / 7	7 / 7	2 / 7
Dose Escalation 1200 mg QD Patients who received 1200 mg once daily under fasted conditions.	1 / 6	6 / 6	1 / 6
Dose Escalation 400 mg BID Patients who received 400 mg twice daily under not fasted conditions.	1 / 4	4 / 4	1 / 4
Dose Escalation 600 mg BID Patients who received 600 mg twice daily under not fasted conditions.	2 / 6	6 / 6	1 / 6
Dose Escalation 800 mg BID Patients who received 800 mg twice daily under fasted conditions.	3 / 5	5 / 5	0 / 5
Safety Expansion 800 mg QD Safety expansion group of patients who received 800 mg once daily under not fasted conditions.	4 / 17	17 / 17	10 / 17

Group identifiers: EG000: Dose Escalation 25 mg QD · EG001: Dose Escalation 50 mg QD · EG002: Dose Escalation 100 mg QD · EG003: Dose Escalation 200 mg QD · EG004: Dose Escalation 400 mg QD · EG005: Dose Escalation 800 mg QD · EG006: Dose Escalation 800 mg QD NF · EG007: Dose Escalation 1000 mg QD · EG008: Dose Escalation 1200 mg QD · EG009: Dose Escalation 400 mg BID · EG010: Dose Escalation 600 mg BID · EG011: Dose Escalation 800 mg BID · EG012: Safety Expansion 800 mg QD

Serious 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
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Musculoskeletal chest pain

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
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
5
num At Risk
10
num Events
5
group Id
EG005
num Affected
12
num At Risk
18
num Events
12
group Id
EG006
num Affected
9
num At Risk
13
num Events
9
group Id
EG007
num Affected
5
num At Risk
7
num Events
5
group Id
EG008
num Affected
4
num At Risk
6
num Events
4
group Id
EG009
num Affected
4
num At Risk
4
num Events
4
group Id
EG010
num Affected
5
num At Risk
6
num Events
5
group Id
EG011
num Affected
5
num At Risk
5
num Events
5
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
4
num At Risk
10
num Events
4
group Id
EG005
num Affected
10
num At Risk
18
num Events
10
group Id
EG006
num Affected
8
num At Risk
13
num Events
8
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
6
num Events
3
group Id
EG009
num Affected
3
num At Risk
4
num Events
3
group Id
EG010
num Affected
4
num At Risk
6
num Events
4
group Id
EG011
num Affected
3
num At Risk
5
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
4
num At Risk
10
num Events
4
group Id
EG005
num Affected
9
num At Risk
18
num Events
9
group Id
EG006
num Affected
4
num At Risk
13
num Events
4
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
5
num At Risk
6
num Events
5
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
3
num At Risk
6
num Events
3
group Id
EG011
num Affected
3
num At Risk
5
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
4
num At Risk
18
num Events
4
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
2
num At Risk
6
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
10
num Events
2
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
3
num At Risk
7
num Events
3
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
2
num At Risk
18
num Events
2
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
3
num At Risk
10
num Events
3
group Id
EG005
num Affected
6
num At Risk
18
num Events
6
group Id
EG006
num Affected
5
num At Risk
13
num Events
5
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
10
num Events
2
group Id
EG005
num Affected
7
num At Risk
18
num Events
7
group Id
EG006
num Affected
5
num At Risk
13
num Events
5
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
5
num At Risk
7
num Events
5
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
5
num At Risk
18
num Events
5
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
2
num At Risk
7
num Events
2
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
2
num At Risk
18
num Events
2
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Weight decreased

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
Patients who received doses at 25 mg once daily under fasted conditions.
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Dose Escalation 25 mg QD
deaths Num Affected
0
deaths Num At Risk
1
description
Patients who received doses at 50 mg once daily under fasted conditions.
id
EG001
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Dose Escalation 50 mg QD
deaths Num Affected
0
deaths Num At Risk
1
description
Patients who received doses at 100 mg once daily under fasted conditions.
id
EG002
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Dose Escalation 100 mg QD
deaths Num Affected
0
deaths Num At Risk
2
description
Patients who received doses at 200 mg once daily under fasted conditions.
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Dose Escalation 200 mg QD
deaths Num Affected
2
deaths Num At Risk
10
description
Patients who received 400 mg once daily under fasted conditions.
id
EG004
other Num Affected
10
other Num At Risk
10
serious Num Affected
2
serious Num At Risk
10
title
Dose Escalation 400 mg QD
deaths Num Affected
7
deaths Num At Risk
18
description
Patients who received 800 mg once daily under fasted conditions.
id
EG005
other Num Affected
18
other Num At Risk
18
serious Num Affected
8
serious Num At Risk
18
title
Dose Escalation 800 mg QD
deaths Num Affected
2
deaths Num At Risk
13
description
Patients who received 800 mg once daily under not fasted (NF) conditions.
id
EG006
other Num Affected
13
other Num At Risk
13
serious Num Affected
1
serious Num At Risk
13
title
Dose Escalation 800 mg QD NF
deaths Num Affected
2
deaths Num At Risk
7
description
Patients who received 1000 mg once daily under fasted conditions.
id
EG007
other Num Affected
7
other Num At Risk
7
serious Num Affected
1
serious Num At Risk
7
title
Dose Escalation 1000 mg QD
deaths Num Affected
1
deaths Num At Risk
6
description
Patients who received 1200 mg once daily under fasted conditions.
id
EG008
other Num Affected
6
other Num At Risk
6
serious Num Affected
1
serious Num At Risk
6
title
Dose Escalation 1200 mg QD
deaths Num Affected
1
deaths Num At Risk
4
description
Patients who received 400 mg twice daily under not fasted conditions.
id
EG009
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Dose Escalation 400 mg BID
deaths Num Affected
1
deaths Num At Risk
6
description
Patients who received 600 mg twice daily under not fasted conditions.
id
EG010
other Num Affected
6
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Dose Escalation 600 mg BID
deaths Num Affected
0
deaths Num At Risk
5
description
Patients who received 800 mg twice daily under fasted conditions.
id
EG011
other Num Affected
5
other Num At Risk
5
serious Num Affected
3
serious Num At Risk
5
title
Dose Escalation 800 mg BID

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
5
num At Risk
10
num Events
5
group Id
EG005
num Affected
12
num At Risk
18
num Events
12
group Id
EG006
num Affected
9
num At Risk
13
num Events
9
group Id
EG007
num Affected
5
num At Risk
7
num Events
5
group Id
EG008
num Affected
4
num At Risk
6
num Events
4
group Id
EG009
num Affected
4
num At Risk
4
num Events
4
group Id
EG010
num Affected
5
num At Risk
6
num Events
5
group Id
EG011
num Affected
5
num At Risk
5
num Events
5
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
4
num At Risk
10
num Events
4
group Id
EG005
num Affected
10
num At Risk
18
num Events
10
group Id
EG006
num Affected
8
num At Risk
13
num Events
8
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
3
num At Risk
6
num Events
3
group Id
EG009
num Affected
3
num At Risk
4
num Events
3
group Id
EG010
num Affected
4
num At Risk
6
num Events
4
group Id
EG011
num Affected
3
num At Risk
5
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
4
num At Risk
10
num Events
4
group Id
EG005
num Affected
9
num At Risk
18
num Events
9
group Id
EG006
num Affected
4
num At Risk
13
num Events
4
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
5
num At Risk
6
num Events
5
group Id
EG009
num Affected
2
num At Risk
4
num Events
2
group Id
EG010
num Affected
3
num At Risk
6
num Events
3
group Id
EG011
num Affected
3
num At Risk
5
num Events
3
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
4
num At Risk
18
num Events
4
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
2
num At Risk
6
num Events
2
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
10
num Events
2
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
2
num At Risk
13
num Events
2
group Id
EG007
num Affected
3
num At Risk
7
num Events
3
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
2
num At Risk
18
num Events
2
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
3
num At Risk
10
num Events
3
group Id
EG005
num Affected
6
num At Risk
18
num Events
6
group Id
EG006
num Affected
5
num At Risk
13
num Events
5
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
10
num Events
2
group Id
EG005
num Affected
7
num At Risk
18
num Events
7
group Id
EG006
num Affected
5
num At Risk
13
num Events
5
group Id
EG007
num Affected
4
num At Risk
7
num Events
4
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
5
num At Risk
7
num Events
5
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
2
num At Risk
5
num Events
2
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
5
num At Risk
18
num Events
5
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
2
num At Risk
7
num Events
2
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
2
num At Risk
18
num Events
2
group Id
EG006
num Affected
1
num At Risk
13
num Events
1
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
1
num At Risk
4
num Events
1
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
1
num At Risk
5
num Events
1
term
Weight decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
1
num At Risk
10
num Events
1
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
1
num At Risk
6
num Events
1
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Anorectal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
1
num At Risk
6
num Events
1
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
1
num At Risk
7
num Events
1
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
0
num At Risk
18
num Events
0
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Failure to thrive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Hypercalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
0
num At Risk
1
num Events
0
group Id
EG002
num Affected
0
num At Risk
1
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
0
num At Risk
10
num Events
0
group Id
EG005
num Affected
1
num At Risk
18
num Events
1
group Id
EG006
num Affected
0
num At Risk
13
num Events
0
group Id
EG007
num Affected
0
num At Risk
7
num Events
0
group Id
EG008
num Affected
0
num At Risk
6
num Events
0
group Id
EG009
num Affected
0
num At Risk
4
num Events
0
group Id
EG010
num Affected
0
num At Risk
6
num Events
0
group Id
EG011
num Affected
0
num At Risk
5
num Events
0
term
Musculoskeletal chest pain

time Frame

Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).

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Preserved source evidence · Not medical advice