A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Terminated

CT.gov ID

NCT02541604

Collaborator

(none)

Enrollment

Locations

Arm

42.2

Actual Duration (Months)

2.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This early phase, multicenter, open-label, single-arm study evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult participants with solid tumors for which prior treatment was proven to be ineffective.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: Atezolizumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Early-Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

Actual Study Start Date :

Nov 30, 2015

Actual Primary Completion Date :

Jun 6, 2019

Actual Study Completion Date :

Jun 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atezolizumab Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.	Drug: Atezolizumab Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle. Other Names: RO5541267; MPDL3280A; Tecentriq

Arm

Intervention/Treatment

Experimental: Atezolizumab

Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.

Drug: Atezolizumab

Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.

Other Names:

RO5541267; MPDL3280A; Tecentriq

Outcome Measures

Primary Outcome Measures

Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT) [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors [Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma [Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT [Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest [From baseline up to approximately 42 months]
Maximum Serum Concentration (Cmax) of Atezolizumab [Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)]
Minimum Serum Concentration (Cmin) of Atezolizumab [PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)]
Atezolizumab Serum Concentration at Washout [At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)]
Area Under the Concentration-Time Curve (AUC) of Atezolizumab [PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)]
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)]

Secondary Outcome Measures

Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Overall Survival (OS) [Baseline until death (up to approximately 42 months)]
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)]
Optimal Dose of Atezolizumab in Pediatric Adult Participants [From baseline up to approximately 42 months]
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Optimal Dose of Atezolizumab in Young Adult Participants [From baseline up to approximately 42 months]
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pediatric solid tumor (including Hodgkin's and Non-Hodgkin's lymphoma), for which prior treatment had proven to be ineffective (that is, relapsed or refractory) or intolerable
Disease that is measurable as defined by RECIST v1.1, mINRC, Revised Response Criteria for Malignant Lymphoma, RANO criteria (as appropriate) or evaluable by nuclear medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable measures
Archival tumor tissue block or 15 freshly cut, unstained, serial slides available for submission, or willingness to undergo a core or excisional biopsy prior to enrollment (fine-needle aspiration, brush biopsy, and lavage samples are not acceptable).

Participants with fewer than 15 slides available may be eligible for study entry following discussion with Medical Monitor

Lansky Performance Status (participants less than [<] 16 years old) or Karnofsky Performance Status (participants greater than or equal to [>=] 16 years old) >=50
Life expectancy >=3 months, in the investigator's judgment
Adequate hematologic and end organ function, confirmed by laboratory results obtained within 28 days prior to initiation of study drug

Exclusion Criteria:

Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases, except ATRT
Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within 3 months prior to initiation of study drug
Prior allogeneic hematopoietic stem-cell transplantation or prior solid-organ transplantation
Treatment with chemotherapy (other than high-dose chemotherapy as described above) or differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2 antibody treatment) within 3 weeks prior to initiation of study drug or, if treatment included nitrosoureas, within 6 weeks prior to initiation of study drug
Treatment with thoracic or mediastinal radiotherapy within 3 weeks prior to initiation of study drug
Treatment with hormonal therapy (except hormone replacement therapy or oral contraceptives) or biologic therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to initiation of study drug. This requirement may be waived at the investigator's request if the participant has recovered from therapeutic toxicity to the degree specified in the protocol, with approval of the Medical Monitor
Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to initiation of study drug or a short-acting hematopoietic growth factor within 1 week prior to initiation of study drug
Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
Treatment with a live vaccine or a live, attenuated vaccine (e.g., nasal spray of live attenuated influenza vaccine or FluMist®) within 4 weeks prior to initiation of study drug or anticipation that such treatment will be required during the study or within 5 months after the final dose of study drug
Treatment with herbal cancer therapy within 1 week prior to initiation of study drug
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin 2 [IL-2]) within 6 weeks or five drug elimination half-lives prior to Day 1 of Cycle 1, whichever is longer
Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) at the time of initiation of study drug, or anticipated requirement for systemic immunosuppressive medications during the study
Current treatment with therapeutic anticoagulants
Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children'S Hospital	Little Rock	Arkansas	United States	72202
2	Stanford University/Lucile Packard Children's Hospital	Palo Alto	California	United States	94304
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
4	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
5	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
8	Alberta Children'S Hospital	Calgary	Alberta	Canada	T3B 6A8
9	Rigshospitalet; BØRNEUNGEKLINIKKEN, Ambulatoriet for kræft- og Blodsygdomme hos børn og unge	København Ø		Denmark	2100
10	Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique	Lyon		France	69373
11	Institut Curie, Oncologie Pédiatrique	Paris		France	75231
12	Institut Gustave Roussy; Service Pediatrique	Villejuif		France	94805
13	Klinik Johann Wolfgang von Goethe Uni	Frankfurt		Germany	60590
14	Schneider Children's Medical Center	Petach-Tikva		Israel	49100
15	Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica	Roma	Lazio	Italy	00165
16	IRCCS Istituto Giannina Gaslini; Unità Operativa Oncologica Pediatrica	Genova	Liguria	Italy	16147
17	Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica	Milano	Lombardia	Italy	20133
18	Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino	Torino	Piemonte	Italy	10126
19	Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica	Padova	Veneto	Italy	35128
20	Erasmus MC / location Sophia Kinderziekenhuis	Rotterdam		Netherlands	3015 GJ
21	Hospital Sant Joan De Deu	Esplugues De Llobregas	Barcelona	Spain	08950
22	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
23	Hospital Infantil Universitario Nino Jesus	Madrid		Spain	28009
24	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
25	Universitäts-Kinderspital; Abteilung für Onkologie	Zürich		Switzerland	8032
26	Birmingham Children's Hospital	Birmingham		United Kingdom	B4 6NH
27	Bristol Royal Hospital For Children	Bristol		United Kingdom	BS2 8BJ
28	Leeds General Infirmary; Paediatric Oncology & Haematology	Leeds		United Kingdom	LS1 3EX
29	The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit	Newcastle Upon Tyne		United Kingdom	NE1 4LP
30	Royal Marsden Hospital; Pediatric Unit	Surrey		United Kingdom	SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Oct 21, 2016

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02541604

Other Study ID Numbers:

GO29664
2014-004697-41

First Posted:

Sep 4, 2015

Last Update Posted:

Feb 25, 2020

Last Verified:

Feb 1, 2020

Additional relevant MeSH terms:

Neoplasms

Atezolizumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	COHORT 1	COHORT 2	COHORT 3	COHORT 4	COHORT 5	COHORT 6	COHORT 7	COHORT 8	COHORT 9	COHORT 10	COHORT 11	COHORT 12
Arm/Group Description	EWING SARCOMA	HODGKIN LYMPHOMA	NEUROBLASTOMA	NON HODGKIN LYMPHOMA	NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;	OSTEOSARCOMA	RHABDOMYOSARCOMA	WILMS TUMOR	OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION	OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION	RHABDOID TUMOR	ATYPICAL TERATOID RHABDOID TUMOR
Period Title: Overall Study
STARTED	11	9	11	3	10	10	10	10	4	4	2	3
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	11	9	11	3	10	10	10	10	4	4	2	3

Baseline Characteristics

Arm/Group Title	COHORT 1	COHORT 2	COHORT 3	COHORT 4	COHORT 5	COHORT 6	COHORT 7	COHORT 8	COHORT 9	COHORT 10	COHORT 11	COHORT 12	Total
Arm/Group Description	EWING SARCOMA	HODGKIN LYMPHOMA	NEUROBLASTOMA	NON HODGKIN LYMPHOMA	NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;	OSTEOSARCOMA	RHABDOMYOSARCOMA	WILMS TUMOR	OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION	OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION	RHABDOID TUMOR	ATYPICAL TERATOID RHABDOID TUMOR	Total of all reporting groups
Overall Participants	11	9	11	3	10	10	10	10	4	4	2	3	87
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	13.6 (3.3)	14.2 (3.0)	12.8 (9.4)	19.0 (6.6)	14.5 (6.5)	17.1 (4.1)	13.0 (8.5)	12.6 (6.8)	14.8 (1.0)	11.3 (0.5)	0.5 (0.7)	7.3 (4.6)	13.5 (6.4)
Sex: Female, Male (Count of Participants)
Female	5 45.5%	6 66.7%	4 36.4%	0 0%	5 50%	4 40%	4 40%	6 60%	0 0%	4 100%	1 50%	1 33.3%	40 46%
Male	6 54.5%	3 33.3%	7 63.6%	3 100%	5 50%	6 60%	6 60%	4 40%	4 100%	0 0%	1 50%	2 66.7%	47 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 18.2%	1 11.1%	2 18.2%	1 33.3%	1 10%	2 20%	3 30%	1 10%	2 50%	0 0%	0 0%	1 33.3%	16 18.4%
Not Hispanic or Latino	7 63.6%	5 55.6%	7 63.6%	2 66.7%	5 50%	6 60%	6 60%	6 60%	2 50%	3 75%	2 100%	0 0%	51 58.6%
Unknown or Not Reported	2 18.2%	3 33.3%	2 18.2%	0 0%	4 40%	2 20%	1 10%	3 30%	0 0%	1 25%	0 0%	2 66.7%	20 23%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	1 10%	0 0%	0 0%	1 25%	0 0%	0 0%	1 33.3%	3 3.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 9.1%	1 33.3%	0 0%	1 10%	0 0%	1 10%	1 25%	1 25%	0 0%	0 0%	6 6.9%
White	8 72.7%	5 55.6%	5 45.5%	2 66.7%	6 60%	6 60%	8 80%	5 50%	1 25%	2 50%	2 100%	0 0%	50 57.5%
More than one race	1 9.1%	0 0%	1 9.1%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 2.3%
Unknown or Not Reported	2 18.2%	4 44.4%	4 36.4%	0 0%	4 40%	2 20%	2 20%	4 40%	1 25%	1 25%	0 0%	2 66.7%	26 29.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors
Description	Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11
Arm/Group Description	Participants with ewing sarcoma	Participants with non-rhabdomyosarcoma soft tissue sarcoma	Participants with osteosarcoma.	Participants with rhabdomyosarcoma	Participants with wilms tumor	Participants with other tumor types with documented PD-L1 expression.	Participants with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.
Measure Participants	11	10	10	10	10	4	4	2
Number [Percentage]	0	10.0	0	0	0	0	0	0

2. Primary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma.
Measure Participants	11
Number [Percentage]	0

3. Primary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with Hodgkin's lymphoma	Participants with non-Hodgkin's lymphoma
Measure Participants	9	3
Number [Percentage]	22.2	33.3

4. Primary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT)
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 12
Arm/Group Description	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	3
Number [Percentage]	0

5. Primary Outcome

Title	Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population (defined as patients who received any amount of study drug), in the Osteosarcoma cohort as per protocol. (Objective response for the other cohorts are measured with different response criteria, and these are described in Outcome Measures 1, 2, 3, and 4).

Arm/Group Title	Cohort 6
Arm/Group Description	Participants with osteosarcoma.
Measure Participants	10
Number [Percentage]	0

6. Primary Outcome

Title	Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
Description
Time Frame	Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11
Arm/Group Description	Participants with ewing sarcoma.	Participants with non-rhabdomyosarcoma soft tissue sarcoma	Participants with osteosarcoma.	Participants with rhabdomyosarcoma.	Participants with wilms tumor.	Participants with other tumor types with documented PD-L1 expression.	Participant with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.
Measure Participants	11	10	10	10	10	4	4	2
Median (95% Confidence Interval) [Months]	1.2	1.3	1.2	1.1	1.3	1.2	1.2	0.7

7. Primary Outcome

Title	PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Description
Time Frame	Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma.
Measure Participants	11
Median (95% Confidence Interval) [Months]	2.6

8. Primary Outcome

Title	PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with hodgkin's lymphoma.	Participants with non-hodgkin's lymphoma.
Measure Participants	9	3
Median (95% Confidence Interval) [Months]	2.8	1.4

9. Primary Outcome

Title	PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Description
Time Frame	Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 12
Arm/Group Description	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	3
Median (95% Confidence Interval) [Months]	1.4

10. Primary Outcome

Title	Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Description
Time Frame	From baseline up to approximately 42 months

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Atezolizumab
Arm/Group Description	Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Measure Participants	87
Adverse Events	97.7
Serious Adverse Events	37.9
Adverse Events of Special Interest	44.8

11. Primary Outcome

Title	Maximum Serum Concentration (Cmax) of Atezolizumab
Description
Time Frame	Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)

Outcome Measure Data

Analysis Population Description
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.

Arm/Group Title	<2 Age (Years)	2 to <12 Age (Years)	12 to <18 Age (Years)	>=18 Age (Years)
Arm/Group Description	Participants <2 Age (Years)	Participants 2 to <12 Age (Years)	Participants 12 to <18 Age (Years)	Participants >=18 Age (Years)
Measure Participants	2	26	34	18
Cycle 1	105 (6.90)	312 (28.7)	337 (26.8)	424 (26.9)
Cycle 4	382 (16.4)	373 (78.9)	626 (29.2)

12. Primary Outcome

Title	Minimum Serum Concentration (Cmin) of Atezolizumab
Description
Time Frame	PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.

Arm/Group Title	<2 Age (Years)	2 to <12 Age (Years)	12 to <18 Age (Years)	>=18 Age (Years)
Arm/Group Description	Participants <2 Age (Years)	Participants 2 to <12 Age (Years)	Participants 12 to <18 Age (Years)	Participants >=18 Age (Years)
Measure Participants	1	25	32	16
Cycle 2	24.1 (NA)	59.3 (31.4)	56.5 (50.4)	79.9 (52.7)
Cycle 3	58.9 (234.4)	85.0 (47.4)	148 (48.9)
Cycle 4	99.2 (36.4)	113 (41.1)	121 (80.4)
Cycle 8	166 (19.8)	145 (21.9)	209 (8.10)

13. Primary Outcome

Title	Atezolizumab Serum Concentration at Washout
Description
Time Frame	At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.

Arm/Group Title	Atezolizumab
Arm/Group Description	Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Measure Participants	17
Geometric Mean (Geometric Coefficient of Variation) [ug/mL]	1.91 (2815.1)

14. Primary Outcome

Title	Area Under the Concentration-Time Curve (AUC) of Atezolizumab
Description
Time Frame	PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)

Outcome Measure Data

Analysis Population Description
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.

Arm/Group Title	<2 Age (Years)	2 to <12 Age (Years)	12 to <18 Age (Years)	>=18 Age (Years)
Arm/Group Description	Participants <2 Age (Years)	Participants 2 to <12 Age (Years)	Participants 12 to <18 Age (Years)	Participants >=18 Age (Years)
Measure Participants	2	29	38	18
Geometric Mean (Geometric Coefficient of Variation) [ugxday/mL]	1130 (5.28)	2209 (21.3)	2816 (17.7)	3579 (28.4)

15. Primary Outcome

Title	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Description
Time Frame	PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.

Arm/Group Title	Atezolizumab
Arm/Group Description	Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Measure Participants	78
Baseline	2.6
Post-baseline	14.3

16. Secondary Outcome

Title	Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11
Arm/Group Description	Participants with ewing sarcoma	Participants with non-rhabdomyosarcoma soft tissue sarcoma.	Participants with osteosarcoma.	Participants with rhabdomyosarcoma	Participants with wilms tumor.	Participants with other tumor types with documented PD-L1 expression.	Participants with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.
Measure Participants	0	1	0	0	0	0	0	0
Median (95% Confidence Interval) [Months]	13.2

17. Secondary Outcome

Title	DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma.
Measure Participants	0

18. Secondary Outcome

Title	DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with hodgkin lymphoma.	Participants with non-hodgkin's lymphoma
Measure Participants	2	1
Median (95% Confidence Interval) [Months]	NA	NA

19. Secondary Outcome

Title	DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had an objective response in this cohort.

Arm/Group Title	Cohort 12
Arm/Group Description	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	0

20. Secondary Outcome

Title	Overall Survival (OS)
Description
Time Frame	Baseline until death (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Atezolizumab
Arm/Group Description	Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Measure Participants	87
Median (95% Confidence Interval) [Months]	7.4

21. Secondary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11	Cohort 12
Arm/Group Description	Participants with ewing sarcoma.	Participants with non-rhabdomyosarcoma.	Participants with osteosarcoma.	Participants with rhabdomyosarcoma.	Participants with wilms tumor.	Participants with other tumor types with documented PD-L1 expression.	Participants with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	11	10	10	10	10	4	4	2	3
Number [Percentage]	0	10	0	0	0	0	0	0	0

22. Secondary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma.
Measure Participants	11
Number [Percentage]	0

23. Secondary Outcome

Title	Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with hodgkin's lymphoma.	Participants with non-hodgkin lymphoma.
Measure Participants	9	3
Number [Percentage]	33.3	33.3

24. Secondary Outcome

Title	PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11	Cohort 12
Arm/Group Description	Participants with ewing sarcoma.	Participants with non-rhabdomyosarcoma soft tissue sarcoma.	Participants with osteosarcoma.	Participants with rhabdomyosarcoma.	Participants with wilms tumor.	Participants with other tumor types with documented PD-L1 expression.	Participants with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	11	10	10	10	10	4	4	2	3
Median (95% Confidence Interval) [Months]	1.3	1.4	1.2	1.3	1.4	1.2	1.2	0.7	6.9

25. Secondary Outcome

Title	PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma
Measure Participants	11
Median (95% Confidence Interval) [Months]	6.9

26. Secondary Outcome

Title	PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with hodgkin lymphoma	Participants with non-hodgkin's lymphoma
Measure Participants	9	3
Median (95% Confidence Interval) [Months]	6.5	3.7

27. Secondary Outcome

Title	DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 1	Cohort 5	Cohort 6	Cohort 7	Cohort 8	Cohort 9	Cohort 10	Cohort 11	Cohort 12
Arm/Group Description	Participants with ewing sarcoma.	Participants with non-rhabdomyosarcoma soft tissue sarcoma.	Participants with osteosarcoma.	Participants with rhabdomyosarcoma.	Participants with wilms tumor.	Participants with other tumor types with documented PD-L1 expression.	Participants with other tumor types without documented PD-L1 expression.	Participants with rhabdoid tumor.	Participants with atypical teratoid rhabdoid tumor.
Measure Participants	0	1	0	0	0	0	0	0	0
Median (95% Confidence Interval) [Months]	13.2

28. Secondary Outcome

Title	DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had response therefore no participants analyzed.

Arm/Group Title	Cohort 3
Arm/Group Description	Participants with neuroblastoma
Measure Participants	0

29. Secondary Outcome

Title	DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Description
Time Frame	Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Outcome Measure Data

Analysis Population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.

Arm/Group Title	Cohort 2	Cohort 4
Arm/Group Description	Participants with Hodgkin lymphoma.	Participants with non-hodgkin's lymphoma
Measure Participants	3	1
Median (95% Confidence Interval) [Months]	NA	NA

30. Secondary Outcome

Title	Optimal Dose of Atezolizumab in Pediatric Adult Participants
Description	Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Time Frame	From baseline up to approximately 42 months

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	<18 Age (Years)
Arm/Group Description	Participants <18 Age (Years)
Measure Participants	69
Number [mg/kg]	15

31. Secondary Outcome

Title	Optimal Dose of Atezolizumab in Young Adult Participants
Description	Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Time Frame	From baseline up to approximately 42 months

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title	>=18 Age (Years)
Arm/Group Description	Participants >=18 Age (Years)
Measure Participants	18
Number [mg]	1200

Adverse Events

	COHORT 1		COHORT 2		COHORT 3		COHORT 4		COHORT 5		COHORT 6		COHORT 7		COHORT 8		COHORT 9		COHORT 10		COHORT 11		COHORT 12
Time Frame	From baseline up to approximately 42 months
Adverse Event Reporting Description	Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.

Arm/Group Title	COHORT 1		COHORT 2		COHORT 3		COHORT 4		COHORT 5		COHORT 6		COHORT 7		COHORT 8		COHORT 9		COHORT 10		COHORT 11		COHORT 12
Arm/Group Description	EWING SARCOMA		HODGKIN LYMPHOMA		NEUROBLASTOMA		NON HODGKIN LYMPHOMA		NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;		OSTEOSARCOMA		RHABDOMYOSARCOMA		WILMS TUMOR		OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION		OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION		RHABDOID TUMOR		ATYPICAL TERATOID RHABDOID TUMOR
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/11 (54.5%)		5/9 (55.6%)		7/11 (63.6%)		2/3 (66.7%)		9/10 (90%)		8/10 (80%)		9/10 (90%)		9/10 (90%)		3/4 (75%)		4/4 (100%)		2/2 (100%)		3/3 (100%)
Serious Adverse Events
	COHORT 1		COHORT 2		COHORT 3		COHORT 4		COHORT 5		COHORT 6		COHORT 7		COHORT 8		COHORT 9		COHORT 10		COHORT 11		COHORT 12
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/11 (36.4%)		3/9 (33.3%)		2/11 (18.2%)		0/3 (0%)		3/10 (30%)		6/10 (60%)		3/10 (30%)		5/10 (50%)		2/4 (50%)		3/4 (75%)		1/2 (50%)		1/3 (33.3%)
Blood and lymphatic system disorders
ANAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FEBRILE NEUTROPENIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Eye disorders
PAPILLOEDEMA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
Gastrointestinal disorders
ABDOMINAL DISTENSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CONSTIPATION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LARGE INTESTINAL OBSTRUCTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PANCREATITIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
UPPER GASTROINTESTINAL HAEMORRHAGE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
General disorders
CHEST PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FATIGUE	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PYREXIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	3	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Hepatobiliary disorders
CHOLESTASIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Immune system disorders
GRAFT VERSUS HOST DISEASE	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Infections and infestations
ABDOMINAL ABSCESS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DEVICE RELATED INFECTION	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
INCISION SITE ABSCESS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LUNG INFECTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	1/2 (50%)	1	0/3 (0%)	0
POSTOPERATIVE ABSCESS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PYELONEPHRITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RESPIRATORY TRACT INFECTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SEPTIC SHOCK	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
STAPHYLOCOCCAL SEPSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URINARY TRACT INFECTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Injury, poisoning and procedural complications
POSTOPERATIVE HYPOTENSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TOXICITY TO VARIOUS AGENTS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Metabolism and nutrition disorders
DEHYDRATION	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DIABETIC KETOACIDOSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
HYPONATRAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
BONE PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FLANK PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Nervous system disorders
HEADACHE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
HYDROCEPHALUS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
PARAESTHESIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
VITH NERVE DISORDER	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
Psychiatric disorders
AGITATION	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Renal and urinary disorders
HYDRONEPHROSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URINARY TRACT OBSTRUCTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PLEURAL EFFUSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/4 (25%)	4	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PNEUMOTHORAX	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
PRURITUS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
RASH MACULO-PAPULAR	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TOXIC SKIN ERUPTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Vascular disorders
SHOCK HAEMORRHAGIC	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SUPERIOR VENA CAVA SYNDROME	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	COHORT 1		COHORT 2		COHORT 3		COHORT 4		COHORT 5		COHORT 6		COHORT 7		COHORT 8		COHORT 9		COHORT 10		COHORT 11		COHORT 12
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/11 (100%)		8/9 (88.9%)		11/11 (100%)		3/3 (100%)		10/10 (100%)		10/10 (100%)		10/10 (100%)		10/10 (100%)		4/4 (100%)		3/4 (75%)		2/2 (100%)		2/3 (66.7%)
Blood and lymphatic system disorders
ANAEMIA	3/11 (27.3%)	4	1/9 (11.1%)	1	3/11 (27.3%)	6	1/3 (33.3%)	1	5/10 (50%)	12	2/10 (20%)	2	3/10 (30%)	3	2/10 (20%)	2	1/4 (25%)	1	1/4 (25%)	1	1/2 (50%)	1	1/3 (33.3%)	1
FEBRILE NEUTROPENIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LEUKOPENIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LYMPHADENOPATHY	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LYMPHOPENIA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NEUTROPENIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
THROMBOCYTOPENIA	2/11 (18.2%)	3	2/9 (22.2%)	2	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
THROMBOCYTOSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Cardiac disorders
PERICARDIAL EFFUSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SINUS TACHYCARDIA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TACHYCARDIA	1/11 (9.1%)	1	1/9 (11.1%)	1	0/11 (0%)	0	1/3 (33.3%)	1	1/10 (10%)	1	1/10 (10%)	1	2/10 (20%)	2	1/10 (10%)	1	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Congenital, familial and genetic disorders
FANCONI SYNDROME	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
Ear and labyrinth disorders
EAR PAIN	1/11 (9.1%)	1	2/9 (22.2%)	3	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VERTIGO	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Endocrine disorders
HYPERTHYROIDISM	0/11 (0%)	0	2/9 (22.2%)	3	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOTHYROIDISM	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
Eye disorders
ECZEMA EYELIDS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
EYELID PTOSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OPSOCLONUS MYOCLONUS	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PERIORBITAL OEDEMA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PHOTOPHOBIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	3	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PHOTOPSIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VISION BLURRED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
Gastrointestinal disorders
ABDOMINAL PAIN	3/11 (27.3%)	3	2/9 (22.2%)	2	2/11 (18.2%)	2	0/3 (0%)	0	2/10 (20%)	4	3/10 (30%)	3	1/10 (10%)	1	3/10 (30%)	5	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
ABDOMINAL PAIN LOWER	0/11 (0%)	0	1/9 (11.1%)	2	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ABDOMINAL PAIN UPPER	1/11 (9.1%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ANAL INCONTINENCE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ASCITES	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
COLITIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CONSTIPATION	3/11 (27.3%)	6	1/9 (11.1%)	1	2/11 (18.2%)	2	1/3 (33.3%)	1	6/10 (60%)	6	6/10 (60%)	7	2/10 (20%)	2	6/10 (60%)	7	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DENTAL CARIES	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DIARRHOEA	0/11 (0%)	0	2/9 (22.2%)	3	4/11 (36.4%)	5	0/3 (0%)	0	4/10 (40%)	6	4/10 (40%)	5	2/10 (20%)	3	2/10 (20%)	2	1/4 (25%)	1	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
DYSPEPSIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DYSPHAGIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ENTEROCOLITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HAEMATOCHEZIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LIP ULCERATION	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NAUSEA	4/11 (36.4%)	4	1/9 (11.1%)	3	1/11 (9.1%)	2	0/3 (0%)	0	2/10 (20%)	2	4/10 (40%)	7	0/10 (0%)	0	2/10 (20%)	2	1/4 (25%)	2	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NONINFECTIVE GINGIVITIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ODYNOPHAGIA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ORAL PAIN	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PROCTALGIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RECTAL DISCHARGE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
STOMATITIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SUBILEUS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SWOLLEN TONGUE	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
UPPER GASTROINTESTINAL HAEMORRHAGE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VOMITING	3/11 (27.3%)	4	3/9 (33.3%)	6	2/11 (18.2%)	2	0/3 (0%)	0	3/10 (30%)	5	3/10 (30%)	4	1/10 (10%)	2	4/10 (40%)	5	1/4 (25%)	2	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
General disorders
ASTHENIA	1/11 (9.1%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	2	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
AXILLARY PAIN	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CATHETER SITE ERYTHEMA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CHEST DISCOMFORT	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CHEST PAIN	1/11 (9.1%)	1	1/9 (11.1%)	1	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	2/10 (20%)	5	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CHILLS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FACE OEDEMA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FATIGUE	2/11 (18.2%)	3	2/9 (22.2%)	2	3/11 (27.3%)	3	0/3 (0%)	0	4/10 (40%)	13	6/10 (60%)	6	3/10 (30%)	3	6/10 (60%)	7	1/4 (25%)	1	2/4 (50%)	2	0/2 (0%)	0	1/3 (33.3%)	1
GENERALISED OEDEMA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
INFLUENZA LIKE ILLNESS	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	2	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
MALAISE	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NON-CARDIAC CHEST PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OEDEMA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OEDEMA PERIPHERAL	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
PAIN	2/11 (18.2%)	2	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PERIPHERAL SWELLING	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
PYREXIA	3/11 (27.3%)	5	3/9 (33.3%)	9	4/11 (36.4%)	5	2/3 (66.7%)	2	2/10 (20%)	5	8/10 (80%)	14	5/10 (50%)	6	4/10 (40%)	5	1/4 (25%)	2	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
THIRST	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VACCINATION SITE OEDEMA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Hepatobiliary disorders
HYPERBILIRUBINAEMIA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/3 (33.3%)	1	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Infections and infestations
BACTERAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BRONCHITIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CANDIDA URETHRITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CONJUNCTIVITIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DERMATOPHYTOSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DEVICE RELATED INFECTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FUNGAL SKIN INFECTION	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
GENITAL HERPES	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HERPES VIRUS INFECTION	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
INFLUENZA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	2/10 (20%)	3	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LARYNGITIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LUNG INFECTION	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NASOPHARYNGITIS	1/11 (9.1%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ORAL CANDIDIASIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
ORAL HERPES	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PARONYCHIA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PHARYNGITIS	0/11 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
PYELONEPHRITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RHINITIS	0/11 (0%)	0	4/9 (44.4%)	16	2/11 (18.2%)	2	1/3 (33.3%)	1	1/10 (10%)	1	1/10 (10%)	2	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SKIN INFECTION	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
STAPHYLOCOCCAL	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TONSILLITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	0/11 (0%)	0	1/9 (11.1%)	1	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URINARY TRACT INFECTION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VASCULAR DEVICE INFECTION	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VULVITIS	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Injury, poisoning and procedural complications
ARTHROPOD BITE	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
FALL	1/11 (9.1%)	1	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LIMB INJURY	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
POST PROCEDURAL SWELLING	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PROCEDURAL PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
THERMAL BURN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
UROSTOMY COMPLICATION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
WOUND DEHISCENCE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CONTUSION	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Investigations
ALANINE AMINOTRANSFERASE INCREASED	1/11 (9.1%)	1	1/9 (11.1%)	3	3/11 (27.3%)	3	0/3 (0%)	0	1/10 (10%)	1	2/10 (20%)	3	0/10 (0%)	0	1/10 (10%)	1	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
AMYLASE INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ANTITHROMBIN III DECREASED	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ASPARTATE AMINOTRANSFERASE INCREASED	0/11 (0%)	0	1/9 (11.1%)	3	4/11 (36.4%)	4	0/3 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	2/10 (20%)	4	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD ALKALINE PHOSPHATASE INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD BILIRUBIN INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD CHLORIDE DECREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD CREATININE INCREASED	2/11 (18.2%)	2	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	3/10 (30%)	3	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
BLOOD LACTATE DEHYDROGENASE INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD POTASSIUM DECREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD THYROID STIMULATING HORMONE INCREASED	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLOOD URINE PRESENT	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
C-REACTIVE PROTEIN INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CANDIDA TEST POSITIVE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CARDIAC MURMUR	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
GAMMA-GLUTAMYLTRANSFERASE INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
INTERNATIONAL NORMALISED RATIO INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LIPASE INCREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LYMPHOCYTE COUNT DECREASED	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	2/10 (20%)	4	3/10 (30%)	6	0/10 (0%)	0	2/10 (20%)	5	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NEUTROPHIL COUNT DECREASED	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	2/10 (20%)	4	1/10 (10%)	3	0/10 (0%)	0	2/10 (20%)	5	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
NOROVIRUS TEST POSITIVE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OXYGEN SATURATION DECREASED	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PLATELET COUNT DECREASED	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	2/10 (20%)	3	2/10 (20%)	3	0/10 (0%)	0	2/10 (20%)	4	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PROTHROMBIN LEVEL DECREASED	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VITAMIN K DECREASED	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
WEIGHT DECREASED	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	1/3 (33.3%)	1	2/10 (20%)	2	1/10 (10%)	1	1/10 (10%)	1	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
WHITE BLOOD CELL COUNT DECREASED	1/11 (9.1%)	2	0/9 (0%)	0	2/11 (18.2%)	2	0/3 (0%)	0	2/10 (20%)	3	2/10 (20%)	4	0/10 (0%)	0	1/10 (10%)	4	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	1
Metabolism and nutrition disorders
DECREASED APPETITE	4/11 (36.4%)	4	1/9 (11.1%)	1	2/11 (18.2%)	2	0/3 (0%)	0	2/10 (20%)	4	2/10 (20%)	2	1/10 (10%)	1	4/10 (40%)	5	1/4 (25%)	1	0/4 (0%)	0	1/2 (50%)	1	0/3 (0%)	0
DEHYDRATION	2/11 (18.2%)	2	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
HYPERGLYCAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERKALAEMIA	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERNATRAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERTRIGLYCERIDAEMIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERURICAEMIA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOALBUMINAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOCALCAEMIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOKALAEMIA	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	2/10 (20%)	3	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	2/4 (50%)	2	0/2 (0%)	0	0/3 (0%)	0
HYPOMAGNESAEMIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	4	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPONATRAEMIA	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	3/10 (30%)	3	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOPHOSPHATAEMIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	2	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
METABOLIC ACIDOSIS	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERMAGNESAEMIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	3	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	4	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA	1/11 (9.1%)	1	1/9 (11.1%)	1	2/11 (18.2%)	2	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	1/10 (10%)	1	1/10 (10%)	1	0/4 (0%)	0	1/4 (25%)	2	0/2 (0%)	0	0/3 (0%)	0
BACK PAIN	1/11 (9.1%)	1	0/9 (0%)	0	2/11 (18.2%)	3	0/3 (0%)	0	2/10 (20%)	2	1/10 (10%)	4	1/10 (10%)	1	2/10 (20%)	2	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	1/3 (33.3%)	2
FLANK PAIN	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HAEMARTHROSIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
MUSCLE SPASMS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
MUSCULOSKELETAL PAIN	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	2/10 (20%)	2	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
MYALGIA	1/11 (9.1%)	1	1/9 (11.1%)	1	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NECK PAIN	1/11 (9.1%)	1	0/9 (0%)	0	2/11 (18.2%)	2	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	2/4 (50%)	2	0/2 (0%)	0	0/3 (0%)	0
PAIN IN EXTREMITY	2/11 (18.2%)	4	1/9 (11.1%)	2	2/11 (18.2%)	2	0/3 (0%)	0	1/10 (10%)	2	2/10 (20%)	3	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	2/4 (50%)	3	0/2 (0%)	0	0/3 (0%)	0
PAIN IN JAW	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	2	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
JOINT SWELLING	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR INFLAMMATION	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TUMOUR PAIN	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Nervous system disorders
AMPUTATION STUMP PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DYSGEUSIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HEADACHE	2/11 (18.2%)	2	1/9 (11.1%)	8	3/11 (27.3%)	3	1/3 (33.3%)	1	2/10 (20%)	3	2/10 (20%)	8	2/10 (20%)	2	3/10 (30%)	5	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	1/3 (33.3%)	2
HYPOAESTHESIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
MIGRAINE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
MIGRAINE WITH AURA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NEURALGIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	2	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PARAESTHESIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PHANTOM LIMB SYNDROME	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SEIZURE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SOMNOLENCE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TREMOR	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DIZZINESS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	2/10 (20%)	3	0/10 (0%)	0	0/10 (0%)	0	2/4 (50%)	2	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PARAPARESIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Product Issues
DEVICE BREAKAGE	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Psychiatric disorders
AGITATION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ANXIETY	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BRUXISM	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
CONFUSIONAL STATE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DELIRIUM	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DEPRESSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
INSOMNIA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	1/4 (25%)	1	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
IRRITABILITY	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	4	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SLEEP DISORDER	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ABNORMAL BEHAVIOUR	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Renal and urinary disorders
ACUTE KIDNEY INJURY	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DYSURIA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
GLYCOSURIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HAEMATURIA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYDRONEPHROSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NEPHROLITHIASIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
OLIGURIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PROTEINURIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URINARY INCONTINENCE	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URINARY RETENTION	1/11 (9.1%)	1	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Reproductive system and breast disorders
PELVIC PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VAGINAL DISCHARGE	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VAGINAL HAEMORRHAGE	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
CATARRH	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
COUGH	3/11 (27.3%)	4	4/9 (44.4%)	14	2/11 (18.2%)	2	1/3 (33.3%)	1	1/10 (10%)	1	5/10 (50%)	8	0/10 (0%)	0	1/10 (10%)	1	2/4 (50%)	2	1/4 (25%)	1	1/2 (50%)	1	1/3 (33.3%)	1
DYSPHONIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	1/4 (25%)	1	0/2 (0%)	0	0/3 (0%)	0
DYSPNOEA	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	2/10 (20%)	2	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DYSPNOEA EXERTIONAL	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
EPISTAXIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOXIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
IRREGULAR BREATHING	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
LARYNGEAL INFLAMMATION	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
NASAL CONGESTION	1/11 (9.1%)	1	0/9 (0%)	0	2/11 (18.2%)	2	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	2	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DISORDER OROPHARYNGEAL PAIN	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PHARYNGEAL INFLAMMATION	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PLEURAL EFFUSION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PNEUMONITIS	0/11 (0%)	0	2/9 (22.2%)	2	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RHINITIS ALLERGIC	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
STRIDOR	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
TACHYPNOEA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ATELECTASIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OBSTRUCTIVE AIRWAYS DISORDER	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
OROPHARYNGEAL PAIN	0/11 (0%)	0	1/9 (11.1%)	2	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RHINORRHOEA	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
ALOPECIA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
BLISTER	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DERMATITIS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DERMATITIS CONTACT	0/11 (0%)	0	1/9 (11.1%)	2	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
DRY SKIN	0/11 (0%)	0	1/9 (11.1%)	2	1/11 (9.1%)	1	1/3 (33.3%)	2	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ECZEMA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ERYTHEMA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERHIDROSIS	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	2/10 (20%)	3	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PALMAR-PLANTAR	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
ERYTHRODYSAESTHESIA SYNDROME	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PERIORAL DERMATITIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PETECHIAE	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PITYRIASIS ROSEA	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
PRURITUS	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	1/3 (33.3%)	1	2/10 (20%)	2	1/10 (10%)	1	1/10 (10%)	1	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RASH	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RASH MACULO-PAPULAR	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
RASH PRURITIC	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
SKIN DISCOLOURATION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
URTICARIA	1/11 (9.1%)	1	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Surgical and medical procedures
CENTRAL VENOUS CATHETERISATION	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
Vascular disorders
EMBOLISM	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HOT FLUSH	0/11 (0%)	0	1/9 (11.1%)	1	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPERTENSION	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	1/10 (10%)	1	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOTENSION	0/11 (0%)	0	0/9 (0%)	0	1/11 (9.1%)	1	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/4 (25%)	1	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
HYPOVOLAEMIC SHOCK	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0
VENOUS THROMBOSIS	0/11 (0%)	0	0/9 (0%)	0	0/11 (0%)	0	0/3 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/4 (0%)	0	0/4 (0%)	0	0/2 (0%)	0	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title	Medical Communications
Organization	Hoffmann-La Roche
Phone	800-821-8590
Email	genentech@druginfo.com

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT02541604

Other Study ID Numbers:

GO29664
2014-004697-41

First Posted:

Sep 4, 2015

Last Update Posted:

Feb 25, 2020

Last Verified:

Feb 1, 2020

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Outcome Measure Data

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Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact