Trial Outcomes & Findings for Study of Atezolizumab + Bevacizumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma (NCT NCT02724878)

Last Updated: 2025-02-13

Results Overview

The best overall response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CR and PR must meet the following lesion criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). Non-CR/Non-Progressive Disease: Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .

Results posted on

2025-02-13

Participant Flow

Enrollment took place between July 2016 and October 2018.

Participant milestones

Participant milestones
Measure	Bevacizumab And Atezolizumab Combination 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Overall Study STARTED	65
Overall Study Treated	60
Overall Study Responders	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab And Atezolizumab Combination 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Overall Study Still on Active Therapy	15
Overall Study Disease Progression	31
Overall Study Toxicity	5
Overall Study Death	1
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	2
Overall Study Protocol Violation	1
Overall Study Ineligible for Study Drug	5
Overall Study not started	1

Baseline Characteristics

Study of Atezolizumab + Bevacizumab in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Metastasis Stage at Diagnosis M0	8 participants n=5 Participants
Metastasis Stage at Diagnosis M1	16 participants n=5 Participants
Metastasis Stage at Diagnosis Unknown	36 participants n=5 Participants
Histology Clear Cell	18 Participants n=5 Participants
Histology Papillary	12 Participants n=5 Participants
Histology Chromophobe	10 Participants n=5 Participants
Histology Unclassified	9 Participants n=5 Participants
Histology Transcription Factor E3 Translocation	5 Participants n=5 Participants
Histology Collecting Duct	5 Participants n=5 Participants
Histology Medullary	1 Participants n=5 Participants
Sarcomatoid Differentiation	26 Participants n=5 Participants
ECOG Performance Status 00 - Fully Active	29 Participants n=5 Participants
ECOG Performance Status 01 - Restricted	30 Participants n=5 Participants
ECOG Performance Status 02 - Ambulatory and Capable of Self Care	1 Participants n=5 Participants
Prior Nephrectomy	52 Participants n=5 Participants
Prior Systemic Therapy	21 Participants n=5 Participants
Presence of Bone Metastases	1 Participants n=5 Participants
Presence of Liver Metastases	11 Participants n=5 Participants
International Metastatic Renal Cell Carcinoma Database Consortium Risk Group Favorable	9 Participants n=5 Participants
International Metastatic Renal Cell Carcinoma Database Consortium Risk Group Intermediate	33 Participants n=5 Participants
International Metastatic Renal Cell Carcinoma Database Consortium Risk Group Poor	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. The median (range) of treatment time was 9.5 (1-42) cycles, thus participants were assessed up to ~32 months .

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Best Overall Response Rate	33 percentage of participants Interval 25.0 to 42.0

SECONDARY outcome

Population: The number analyzed for each row is less than 60 because each row represents a histological subgroup. The sum of number analyzed by row equals the total number analyze (60).

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Best Overall Response Rate by Histological Subtypes Papillary	23 percentage of participants Interval 10.0 to 48.0
Best Overall Response Rate by Histological Subtypes Chromophobe	10 percentage of participants Interval 1.0 to 34.0
Best Overall Response Rate by Histological Subtypes Unclassified	33 percentage of participants Interval 13.0 to 60.0
Best Overall Response Rate by Histological Subtypes Transcription Factor E3 Translocation	20 percentage of participants Interval 2.0 to 58.0
Best Overall Response Rate by Histological Subtypes Collecting Duct	40 percentage of participants Interval 12.0 to 77.0
Best Overall Response Rate by Histological Subtypes Medullary	100 percentage of participants Interval 10.0 to 100.0
Best Overall Response Rate by Histological Subtypes Clear Cell	50 percentage of participants Interval 33.0 to 67.0

SECONDARY outcome

Timeframe: Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months).

Population: The analysis population is comprised of all treated patients.

Assessed by -Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All treatment-related all-grade adverse events occurring in \>10% of participants. Treatment Related is discerned as follows: * Yes: There is a plausible temporal relationship between the onset of the AE and administration of atezolizumab or bevacizumab, and the AE cannot be readily explained by the patient's clinical state, intercurrent illness, or concomitant therapies; and/or the AE follows a known pattern of response to atezolizumab or bevacizumab or with similar treatments; and/or the AE resolves upon discontinuation of the study drugs or dose reduction and, if applicable, reappears upon re-challenge. * No: Evidence exists that the AE has an etiology other than the study drugs (e.g., pre existing medical condition, underlying disease, intercurrent illness, or concomitant medication); and/or the AE has no plausible temporal relationship to the study drugs administration.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Percentage of Participants With Treatment-related Adverse Events Fatigue	35 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Proteinuria	35 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Musculoskeletal Pain	33 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Diarrhea	22 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Rash	20 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Hypertension	18 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Pruritis	18 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Thyroid Dysfunction	17 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Hepatitis	15 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Fever	13 percentage of participants
Percentage of Participants With Treatment-related Adverse Events Mucositis	12 percentage of participants

SECONDARY outcome

Timeframe: Measured every 6 weeks for the first 24 weeks and then every 12 weeks while on treatment. Off-treatment, patients are followed every 6 months for up to two year. Participants were followed up to 32 months.

The duration of overall response (based on RECIST 1.1) is measured from the time measurement criteria are met for CR and PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented taking as reference for progressive disease the smallest measurements recorded since the treatment started or death due to any cause. Participants without events reported are censored at the last disease evaluation.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=20 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Duration of Response	8.9 months Interval 1.4 to 29.0

SECONDARY outcome

Timeframe: Measured every 6 weeks while on treatment. Off-treatment, patients are followed every 6 months for up to two year. Participants were followed up to 32 months.

Population: Since the trial was designed in 2015, immune-related response has been infrequently used in VEGF/IO trials for kidney cancer. Most RCC trials have mainly focused on the traditional RECIST-based response as the primary endpoint. Therefore, the study team did not pursue immune-related response assessment and that data was not collected.

The best overall Immune-Related Complete Response (irCR) or Immune-Related Partial Response (irPR) is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). irCR: Complete disappearance of all target lesions in two consecutive observations not less than 4 weeks apart. This category encompasses exactly the same subjects as complete response (CR). irPR: Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters (SPD) of all target and all new measurable lesions in two consecutive observations not less than 4 weeks apart. Note: the appearance of new measurable lesions is factored into the overall tumor burden, but does not automatically qualify as progressive disease until the SPD increases by \> 25% when compared to SPD at nadir.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants followed for up to 32 months.

Progression free survival (PFS) is defined as the time from start of treatment to disease progression (PD) or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST) as follows: \- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including baseline if it's the smallest). The sum must also demonstrate an increase of \>5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Median Progression Free Survival	8.3 months Interval 5.7 to 10.9

SECONDARY outcome

Timeframe: 1 year

1-Year Overall Survival (OS) is defined as the probability of survival at 1 year from treatment start date. Survival probability is estimated using Kaplan Meier methods. An event is considered to be death due to any cause. Participants who are lost to follow-up before the 1 year mark are censored at date last known alive.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
1-Year Overall Survival	67 percent probability of survival Interval 52.0 to 79.0

SECONDARY outcome

Timeframe: Assessed at baseline, week 3, week 5, week 7, week 9, and end of therapy.

Population: Number analyzed reflects the number of participants with a evaluable questionnaire at each timepoint.

The Function Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) is a 19 item questionnaire with each item scored on a scale of 0-4 for a total score of 0-76 with higher scores indicating fewer symptom.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score Baseline	55.72 score on scale Interval 48.0 to 64.0
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score 3 weeks	59.13 score on scale Interval 54.0 to 65.0
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score 5 weeks	59.13 score on scale Interval 61.0 to 67.0
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score 7 weeks	60.66 score on scale Interval 52.0 to 70.0
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score 9 weeks	62.41 score on scale Interval 55.0 to 70.0
Mean Function Assessment of Cancer Therapy-Kidney Symptom Index-19 Score End of Therapy	51.92 score on scale Interval 44.0 to 59.0

SECONDARY outcome

Timeframe: Assessed at baseline, week 9, week 15, week 21, week 27, and end of therapy.

Population: Number analyzed reflects the number of participants with a evaluable questionnaire at each timepoint. Items 1-3 are reported because they are fatigue related and fatigue is the most common toxicity in the cohort.

The Brief Fatigue Inventory Score (BFI) is a 9 item questionnaire with each items 1-3 scored on a scale of 0-10 Scores are categorized is mild (1-3), moderate (4-6), or severe (7-10). A global fatigue score can be found by averaging the score obtained on each test item completed. Items 1-3 of the 9 are reported here.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Brief Fatigue Inventory Score - Items 1-3 Baseline	3.56 score on scale Interval 1.0 to 5.3
Brief Fatigue Inventory Score - Items 1-3 Week 9	3.44 score on scale Interval 1.0 to 5.3
Brief Fatigue Inventory Score - Items 1-3 Week 15	3.25 score on scale Interval 1.0 to 5.3
Brief Fatigue Inventory Score - Items 1-3 Week 21	2.97 score on scale Interval 1.3 to 4.7
Brief Fatigue Inventory Score - Items 1-3 Week 27	2.70 score on scale Interval 0.7 to 4.0
Brief Fatigue Inventory Score - Items 1-3 End of Therapy	3.97 score on scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 6 months

Population: Each row represent a histological subgroup

6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows: \- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an increase of \>5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment. Histological subgroups are categorized using established methods.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
6-Month Progression-Free Survival by Histological Subgroups Clear Cell	58 percent probability of PFS Interval 31.0 to 77.0
6-Month Progression-Free Survival by Histological Subgroups Papillary	75 percent probability of PFS Interval 41.0 to 91.0
6-Month Progression-Free Survival by Histological Subgroups Other clear cell Renal Cell Carcinoma	59 percent probability of PFS Interval 39.0 to 74.0

SECONDARY outcome

Timeframe: 1 year

Population: Each row represents a Histology subgroup.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
1-Year Overall Survival by Histological Subgroup Clear Cell	63 percent probability of survival Interval 35.0 to 82.0
1-Year Overall Survival by Histological Subgroup Papillary	79 percent probability of survival Interval 36.0 to 94.0
1-Year Overall Survival by Histological Subgroup Other non-clear cell Renal Cell Carcinoma	68 percent probability of survival Interval 46.0 to 82.0

SECONDARY outcome

Timeframe: 6 months

Population: Each row represents a Sarcomatoid Differentiation category.

6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows: \- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an increase of \>5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment. Sarcomatoid Differentiation are categorized using established methods

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
6-Month Progression-Free Survival by Sarcomatoid Differentiation Sarcomatoid in clear cell Renal Cell Carcinoma	58 percent probability of PFS Interval 31.0 to 77.0
6-Month Progression-Free Survival by Sarcomatoid Differentiation Sarcomatoid in non-clear cell Renal Cell Carcinoma	38 percent probability of PFS Interval 9.0 to 67.0
6-Month Progression-Free Survival by Sarcomatoid Differentiation None	70 percent probability of PFS Interval 51.0 to 82.0

SECONDARY outcome

Timeframe: 1 year

Population: Each row represents a Sarcomatoid Differentiation category.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
1-Year Overall Survival by Sarcomatoid Differentiation Sarcomatoid in clear cell Renal Cell Carcinoma	63 percent probability of survival Interval 35.0 to 82.0
1-Year Overall Survival by Sarcomatoid Differentiation Sarcomatoid in non-clear cell Renal Cell Carcinoma	36 percent probability of survival Interval 1.0 to 78.0
1-Year Overall Survival by Sarcomatoid Differentiation None	74 percent probability of survival Interval 54.0 to 87.0

SECONDARY outcome

Population: Each row represents a Sarcomatoid Differentiation category.

The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response on treatment using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1). CR and PR must meet the following criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): \>=30% decrease in the sum of the diameters of target lesion, taking as reference the baseline sum diameter. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological (\<10 mm short axis) Non-CR/Non-Progressive Disease: Persistence of 1+ non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion Sarcomatoid Differentiation are categorized using established methods

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Objective Response Rate by Sarcomatoid Differentiation None	26 percentage of participants Interval 17.0 to 36.0
Objective Response Rate by Sarcomatoid Differentiation Clear Cell Renal Carcinoma	50 percentage of participants Interval 35.0 to 65.0
Objective Response Rate by Sarcomatoid Differentiation Variant Histology Renal Cell Carcinoma	38 percentage of participants Interval 16.0 to 60.0

SECONDARY outcome

Timeframe: 6 months

Population: Each row represents an International Metastatic Renal Cell Carcinoma Risk Group

6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows: \- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum. The sum must also demonstrate an increase of \>5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at next assessment at investigator discretion if patient is benefiting from treatment. International Metastatic Renal Cell Carcinoma Risk Group determined by established methods

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
6-Month Progression-Free Survival by International Metastatic Renal Cell Carcinoma Risk Group Favorable	78 percent probability of PFS Interval 36.0 to 94.0
6-Month Progression-Free Survival by International Metastatic Renal Cell Carcinoma Risk Group Intermediate	79 percent probability of PFS Interval 61.0 to 89.0
6-Month Progression-Free Survival by International Metastatic Renal Cell Carcinoma Risk Group Poor	19 percent probability of PFS Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: 1 year

Population: Each row represents an International Metastatic Renal Cell Carcinoma Risk Group

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group Poor	28 percent probability of survival Interval 8.0 to 53.0
1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group Favorable	100 percent probability of survival Interval 100.0 to 100.0
1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group Intermediate	79 percent probability of survival Interval 57.0 to 90.0

SECONDARY outcome

Population: Each row represents an International Metastatic Renal Cell Carcinoma Risk Group

The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response on treatment using RECIST 1.1. CR and PR must meet the following criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. (PR): \>=30% decrease in the sum of the diameters of target lesion, taking as reference the baseline sum diameter. Non-Target Lesion: (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological (\<10 mm short axis). Non-CR/Non-Progressive Disease: Persistence of 1+ non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Must have PR in target lesion. International Metastatic Renal Cell Carcinoma Risk Group are categorized using established methods

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Objective Response Rate by International Metastatic Renal Cell Carcinoma Risk Group Favorable	33 percentage of participants Interval 13.0 to 53.0
Objective Response Rate by International Metastatic Renal Cell Carcinoma Risk Group Intermediate	45 percentage of participants Interval 35.0 to 57.0
Objective Response Rate by International Metastatic Renal Cell Carcinoma Risk Group Poor	11 percentage of participants Interval 1.6 to 21.0

SECONDARY outcome

Timeframe: 6 months

Population: Each row represents a prior systemic therapy category.

6-Month Progression free survival (PFS) is defined as the probability of disease progression (PD) or death from any cause 6 months from treatment start date as estimated by Kaplan Meier methods. Patients who have not progressed and alive are censored at the date the patient is known to be progression-free. Progression is defined by RECIST 1.1 as follows: \- \>20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an increase of \>5 mm. OR -Appearance of new lesions and/or unequivocal progression of non-target lesions. It must be representative of overall disease status change, not a single lesion increase. For patients with PD at the first on-treatment imaging assessment, patients will be allowed to remain on study until confirmation at the next assessment at investigator discretion if patient is benefiting from treatment. Prior systemic therapy group determined by established methods,

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
6-Month Progression-Free Survival by Prior Systemic Therapy No	56 percent probability of PFS Interval 39.0 to 71.0
6-Month Progression-Free Survival by Prior Systemic Therapy Yes	71 percent probability of PFS Interval 47.0 to 86.0

SECONDARY outcome

Timeframe: 1 year

Population: Each row represents a prior systemic therapy category.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
1-Year Overall Survival by Prior Systemic Therapy No	66 percent probability of survival Interval 48.0 to 80.0
1-Year Overall Survival by Prior Systemic Therapy Yes	66 percent probability of survival Interval 33.0 to 85.0

SECONDARY outcome

Population: Each row represents a prior systemic therapy category.

Outcome measures

Outcome measures
Measure	Bevacizumab And Atezolizumab Combination n=60 Participants 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Objective Response Rate by Prior Systemic Therapy Yes	31 percentage of participants Interval 25.0 to 52.0
Objective Response Rate by Prior Systemic Therapy No	38 percentage of participants Interval 21.0 to 40.0

Adverse Events

Bevacizumab And Atezolizumab Combination

Serious events: 5 serious events

Other events: 62 other events

Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab And Atezolizumab Combination n=65 participants at risk 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Investigations Alkaline phosphatase increased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Blood bilirubin increased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Pericardial effusion	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Ascites	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Dysphagia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Dyspnea	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Fatigue	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Multi-organ failure	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hyponatremia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Infections and infestations - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Sepsis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Hip fracture	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Anorexia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Acute kidney injury	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.

Other adverse events

Other adverse events
Measure	Bevacizumab And Atezolizumab Combination n=65 participants at risk 1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.
Blood and lymphatic system disorders Anemia	24.6% 16/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Blood and lymphatic system disorders Leukocytosis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Blood and lymphatic system disorders Lymph node pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Atrial fibrillation	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Chest pain - cardiac	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Palpitations	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Pericardial effusion	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Ventricular tachycardia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Cardiac disorders Cardiac disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Ear and labyrinth disorders Tinnitus	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Ear and labyrinth disorders Vertigo	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Endocrine disorders Adrenal insufficiency	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Endocrine disorders Hyperthyroidism	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Endocrine disorders Hypothyroidism	27.7% 18/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Endocrine disorders Endocrine disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Eye disorders Blurred vision	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Eye disorders Cataract	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Eye disorders Floaters	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Eye disorders Eye disorders - Other, specify	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Abdominal distension	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Abdominal pain	18.5% 12/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Ascites	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Bloating	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Colitis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Colonic fistula	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Constipation	32.3% 21/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Diarrhea	40.0% 26/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Dry mouth	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Duodenal ulcer	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Dyspepsia	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Dysphagia	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Gastroesophageal reflux disease	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Gastrointestinal pain	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Gastroparesis	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Hemorrhoidal hemorrhage	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Hemorrhoids	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Lip pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Mucositis oral	10.8% 7/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Nausea	36.9% 24/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Oral dysesthesia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Oral hemorrhage	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Oral pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Rectal hemorrhage	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Stomach pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Vomiting	20.0% 13/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Chills	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Edema limbs	13.8% 9/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Fatigue	78.5% 51/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Fever	18.5% 12/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Flu like symptoms	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Gait disturbance	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Infusion related reaction	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Localized edema	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Multi-organ failure	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Neck edema	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Non-cardiac chest pain	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders Pain	16.9% 11/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
General disorders General disorders and administration site conditions - Other, specify	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Hepatobiliary disorders Portal vein thrombosis	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Immune system disorders Allergic reaction	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Immune system disorders Autoimmune disorder	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Bronchial infection	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Catheter related infection	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Conjunctivitis infective	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Gum infection	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Pharyngitis	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Rhinitis infective	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Sepsis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Sinusitis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Skin infection	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Upper respiratory infection	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Urinary tract infection	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Infections and infestations Infections and infestations - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Fall	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Fracture	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Hip fracture	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Vascular access complication	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Injury, poisoning and procedural complications Wound complication	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Alanine aminotransferase increased	15.4% 10/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Alkaline phosphatase increased	10.8% 7/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Aspartate aminotransferase increased	21.5% 14/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Blood bilirubin increased	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Cholesterol high	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Creatinine increased	16.9% 11/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Lipase increased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Lymphocyte count decreased	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Lymphocyte count increased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Platelet count decreased	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Serum amylase increased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Weight gain	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Investigations Weight loss	12.3% 8/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Acidosis	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Anorexia	23.1% 15/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Dehydration	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypercalcemia	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hyperglycemia	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hyperkalemia	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypoalbuminemia	9.2% 6/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypocalcemia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypoglycemia	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypokalemia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hypomagnesemia	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Hyponatremia	18.5% 12/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Arthralgia	13.8% 9/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Arthritis	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Back pain	52.3% 34/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Bone pain	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Chest wall pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Flank pain	12.3% 8/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased cervical spine	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Myalgia	16.9% 11/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Pain in extremity	26.2% 17/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Amnesia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Dizziness	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Dysgeusia	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Dysphasia	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Headache	21.5% 14/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Memory impairment	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Paresthesia	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Peripheral motor neuropathy	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Peripheral sensory neuropathy	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Somnolence	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Tremor	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Nervous system disorders Nervous system disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Psychiatric disorders Anxiety	13.8% 9/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Psychiatric disorders Confusion	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Psychiatric disorders Depression	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Psychiatric disorders Insomnia	18.5% 12/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Acute kidney injury	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Chronic kidney disease	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Hematuria	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Proteinuria	41.5% 27/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Urinary frequency	9.2% 6/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Urinary tract obstruction	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Renal and urinary disorders Renal and urinary disorders - Other, specify	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Reproductive system and breast disorders Erectile dysfunction	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Reproductive system and breast disorders Gynecomastia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 5/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Cough	27.7% 18/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Dyspnea	36.9% 24/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Hiccups	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Productive cough	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Sinus disorder	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Sneezing	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Bullous dermatitis	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Dry skin	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Erythema multiforme	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Pruritus	20.0% 13/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Rash acneiform	4.6% 3/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 4/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Skin atrophy	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Skin ulceration	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Urticaria	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	10.8% 7/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Flushing	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Hematoma	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Hot flashes	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Hypertension	35.4% 23/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Hypotension	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Thromboembolic event	1.5% 1/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.
Vascular disorders Vascular disorders - Other, specify	3.1% 2/65 • Adverse events are measured continuously on treatment and up to thirty days after going off treatment (up to ~32 months). An adverse event (AE) was classified as serious (SAE) if any of the following are true: * It results in death or is life threatening. * It requires or prolongs inpatient hospitalization. * It results in persistent or significant disability/incapacity . * It results in a congenital anomaly/birth defect in a neonate/infant born to a mother. exposed to the IMP. \- It is considered a significant medical event by the investigator based on medical judgment.

Additional Information

Toni Choueiri

Dana-Farber Cancer Institute

Phone: 617-632-5456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place